HealthyFood

The Clinical Trial Site of ITM is seeking volunteers for a new clinical trial entitled HealthyFood. In this study, we want to investigate whether low doses of antibiotics, which are allowed in our food, can promote resistance of bacteria to antibiotic treatment.

• For whom: Healthy volunteers who are at least 18 years old

• Start: March 2024

• Duration: 30 days

• Study visits: 3 visits to the study centre

• Treatment: Very low dose of antibiotics or placebo syrup

• Compensation: Per study visit, you will receive a fixed compensation. You will receive this gift card upon completion of your study participation, or at your last study visit in case of early termination of your study participation.

Purpose of the study

In our bodies live many different bacteria, which are important for the natural functioning of our bodies. However, it was recently discovered that certain of these bacteria are no longer sensitive to antibiotics. This is not a problem for the natural bacteria, but this resistance to antibiotic treatment could be transferred to bacteria that are harmful to our bodies. When this happens, treatment options are limited, as these harmful bacteria will no longer respond to certain medications.

The reason why certain bacteria develop resistance might be partly due to the intake of very low doses of antibiotics through our food. In this study, therefore, we want to investigate whether such low concentrations of antibiotics, which are allowed in our food, could be driving this resistance.

How does this work?

We will attempt to demonstrate this hypothesis by examining whether a commonly used antibiotic, Ciprofloxacin, can induce resistance to a common gastrointestinal bacterium, Escherichia coli (E. coli). If successful, this makes a strong case for reducing the allowable concentrations of antibiotics in food. However, this is a pilot study, meaning that the results will have to be demonstrated in a larger-scale study at a later date.

The dose of Ciprofloxacin we will use in this study is an extremely low dose, one two-thousandth of the normal dose used to treat infections.

Conduct of the study

For this study, we are looking for 30 healthy volunteers in whom E. coli is present in their gastrointestinal tract. We will examine this during the first study visit. For participants found not to be carriers of the bacteria, the study will stop after this first visit. Those who do carry E. coli will be randomly divided into 2 groups during a second study visit. Here, 20 participants will have to take Ciprofloxacin syrup for 28 days, and 10 participants will have to take a placebo syrup (which is identical in appearance, but contains no active ingredients). You will then make a final visit to the study centre.

To determine the presence of E. coli, you will need to take anal swabs during the first and last visit.

Risks and inconveniences

There are only minor risks foreseen in participating in this study:

• Taking the swabs may be inconvenient and it may be difficult to remember taking the syrup every day. You may also not like the taste of the syrup.

• Ciprofloxacin will be dosed at an extremely low dose. This dose is the same as or lower than those allowed to be eaten in food products in the European Union. The side effects most frequently reported with the use of ciprofloxacin are nausea and diarrhea.

• There is a risk that the very low doses of ciprofloxacin that you may take, could induce resistance to ciprofloxacin in E.coli and other bacteria in your body. It is important to note that this risk is not higher than that imposed by eating food with the currently approved concentrations of ciprofloxacin in Europe.

Compensation

For the expenses you must incur to participate in the study, you will receive a fixed compensation per study visit. You will receive this upon completion of your study participation, or at your last study visit in case of early termination of your study participation.

Questions?

Contact us at studies@itg.be.